Purple Book product · Biosimilar 351(k)
Eydenzelt
aflibercept-boav
Oct 02, 2025
Approved
Biosimilar 351(k)
License type
Rx
Marketing
88
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Oct 02, 2025
10 mo ago
Today
Pharmaceutical detail
Strength
2MG/0.05ML
Dosage form
Injection
Route
Intravitreal
Presentation
Pre-Filled Syringe
Center
CDER
License number
1996
Product number
002
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of aflibercept (Eylea)
Patent list (88)
| Patent | Expires | In | Source |
|---|---|---|---|
| 10,857,231 | Mar 14, 2022 | 4 yr 5 mo ago | FDA |
| 7,070,959 | Jun 16, 2023 | 3 yr 2 mo ago | FDA |
| 10,406,226 | Mar 22, 2026 | 4 mo ago | FDA |
| 10,464,992 | Jun 14, 2027 | in 11 mo | FDA |
| 11,066,458 | Jun 14, 2027 | in 11 mo | FDA |
| 11,084,865 | Jun 14, 2027 | in 11 mo | FDA |
| 11,732,024 | Jun 14, 2027 | in 11 mo | FDA |
| 10,415,055 | Jun 04, 2028 | in 1 yr 11 mo | FDA |
| 9,562,238 | Jun 04, 2028 | in 1 yr 11 mo | FDA |
| 9,932,605 | Jun 04, 2028 | in 1 yr 11 mo | FDA |
| 7,771,997 | Jul 02, 2028 | in 2 yr | FDA |
| 9,222,106 | Jul 02, 2028 | in 2 yr | FDA |
| 10,130,681 | Jan 11, 2032 | in 5 yr 7 mo | FDA |
| 10,828,345 | Jan 11, 2032 | in 5 yr 7 mo | FDA |
| 10,857,205 | Jan 11, 2032 | in 5 yr 7 mo | FDA |
| 10,888,601 | Jan 11, 2032 | in 5 yr 7 mo | FDA |
| 11,253,572 | Jan 11, 2032 | in 5 yr 7 mo | FDA |
| 11,559,564 | Jan 11, 2032 | in 5 yr 7 mo | FDA |
| 11,707,506 | Jan 11, 2032 | in 5 yr 7 mo | FDA |
| 11,975,045 | Jan 11, 2032 | in 5 yr 7 mo | FDA |
| 11,986,511 | Jan 11, 2032 | in 5 yr 7 mo | FDA |
| 12,268,730 | Jan 11, 2032 | in 5 yr 7 mo | FDA |
| 9,669,069 | Jan 11, 2032 | in 5 yr 7 mo | FDA |
| 9,254,338 | May 22, 2032 | in 5 yr 11 mo | FDA |
| 11,332,771 | Mar 14, 2034 | in 7 yr 9 mo | FDA |
| 11,970,724 | Mar 14, 2034 | in 7 yr 9 mo | FDA |
| D858,754 | Sep 03, 2034 | in 8 yr 3 mo | FDA |
| 9,315,281 | Sep 16, 2034 | in 8 yr 3 mo | FDA |
| 11,268,109 | Oct 21, 2035 | in 9 yr 5 mo | FDA |
| 11,788,102 | Oct 21, 2035 | in 9 yr 5 mo | FDA |
| 9,816,110 | Oct 21, 2035 | in 9 yr 5 mo | FDA |
| D906,102 | Dec 29, 2035 | in 9 yr 7 mo | FDA |
| 10,927,342 | Aug 03, 2036 | in 10 yr 2 mo | FDA |
| 11,312,936 | Aug 03, 2036 | in 10 yr 2 mo | FDA |
| 12,221,619 | Aug 03, 2036 | in 10 yr 2 mo | FDA |
| D934,069 | Oct 26, 2036 | in 10 yr 5 mo | FDA |
| 11,549,154 | Dec 25, 2036 | in 10 yr 7 mo | FDA |
| 10,669,594 | Feb 12, 2037 | in 10 yr 9 mo | FDA |
| 11,918,785 | Jun 29, 2037 | in 11 yr 1 mo | FDA |
| 10,182,969 | Jul 13, 2037 | in 11 yr 2 mo | FDA |
| D961,376 | Aug 23, 2037 | in 11 yr 3 mo | FDA |
| D961,377 | Aug 23, 2037 | in 11 yr 3 mo | FDA |
| 11,577,025 | Oct 06, 2037 | in 11 yr 5 mo | FDA |
| 11,680,930 | Oct 25, 2037 | in 11 yr 5 mo | FDA |
| 10,905,786 | Mar 06, 2038 | in 11 yr 10 mo | FDA |
| 10,918,754 | Mar 06, 2038 | in 11 yr 10 mo | FDA |
| 12,116,622 | May 25, 2038 | in 12 yr | FDA |
| 11,769,597 | Aug 15, 2038 | in 12 yr 3 mo | FDA |
| 11,433,186 | Dec 12, 2038 | in 12 yr 7 mo | FDA |
| 12,168,036 | May 10, 2039 | in 13 yr | FDA |
| 11,103,552 | May 15, 2039 | in 13 yr | FDA |
| 10,973,879 | May 17, 2039 | in 13 yr | FDA |
| 12,280,093 | May 17, 2039 | in 13 yr | FDA |
| D1,035,436 | Jul 16, 2039 | in 13 yr 2 mo | FDA |
| D1,042,107 | Sep 17, 2039 | in 13 yr 4 mo | FDA |
| 11,850,407 | Sep 18, 2039 | in 13 yr 4 mo | FDA |
| D1,047,700 | Oct 22, 2039 | in 13 yr 5 mo | FDA |
| 10,961,500 | Jan 27, 2040 | in 13 yr 9 mo | FDA |
| 11,286,460 | Jan 27, 2040 | in 13 yr 9 mo | FDA |
| 11,555,176 | Jan 27, 2040 | in 13 yr 9 mo | FDA |
| 11,821,001 | Jan 27, 2040 | in 13 yr 9 mo | FDA |
| 11,439,758 | Jun 04, 2040 | in 14 yr 1 mo | FDA |
| 11,478,588 | Jul 25, 2040 | in 14 yr 3 mo | FDA |
| 11,160,918 | Jul 29, 2040 | in 14 yr 3 mo | FDA |
| 11,793,926 | Jul 29, 2040 | in 14 yr 3 mo | FDA |
| 11,053,280 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 11,104,715 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 11,174,283 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 11,186,625 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 11,299,532 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 11,306,135 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 11,459,373 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 11,459,374 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 11,472,861 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 11,485,770 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 11,505,593 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 11,535,663 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 11,542,317 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 11,548,932 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 11,649,273 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 11,732,025 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 11,753,459 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 12,054,533 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 12,077,570 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 12,202,883 | Aug 18, 2040 | in 14 yr 4 mo | FDA |
| 11,525,833 | Nov 29, 2040 | in 14 yr 7 mo | FDA |
| 12,282,004 | Dec 09, 2041 | in 15 yr 7 mo | FDA |
| 12,163,122 | May 10, 2042 | in 16 yr 1 mo | FDA |
Source provenance
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
When do Eydenzelt's patents expire?
The FDA Purple Book lists 88 published patents for Eydenzelt, with the last listed patent expiring May 10, 2042. Every patent below links to its FDA source record so you can verify the expiration date.
Is Eydenzelt a biosimilar?
Yes. Eydenzelt is a Biosimilar 351(k) referencing aflibercept, licensed under a 351(k) BLA.
Is Eydenzelt interchangeable?
Eydenzelt is a 351(k) biosimilar but does not carry an interchangeability designation in the Purple Book, so pharmacy-level substitution depends on state law.
What is Eydenzelt's BLA number?
Eydenzelt is licensed under BLA 761377, held by CELLTRION, Inc..
When was Eydenzelt approved by the FDA?
Eydenzelt was approved by the FDA on Oct 02, 2025.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

